[Health-related quality of life after mechanical ventilation in the intensive care unit]. / Gesundheitsbezogene Lebensqualität nach Beatmung auf der Intensivstation.

BACKGROUND: It is unknown whether health related quality of life measured in German patients one year after mechanical ventilation in the intensive care unit is impaired or not. OBJECTIVES: The aim of this study was to assess health related quality of life one year after inclusion into a randomized controlled trial for weaning from mechanical ventilation with the help of a questionnaire that has never been used in critically ill patients and to investigate whether health related quality of life scores differ between the study population and a general German population. METHODS: We followed up with patients one year after inclusion into a randomized control trial investigating the effect of SmartCare/PS on total ventilation time compared to protocol-driven weaning (ASOPI trial, clinicaltrials.gov ID00445289). Health related quality of life was measured using the quality of life questionnaire C­30 version 3.0 from the European Organization of Research and Treatment of Cancer (EORTC). Mean differences of at least 10 score points in the quality of life scales were considered clinically significant. RESULTS: Of the 232 patients who were alive 90 days after study inclusion, 24 patients died one year after study inclusion and 64 patients were lost to follow-up. Of the remaining145 patients who were successfully contacted, 126 patients agreed to fill out the questionnaire. Questionnaires were sent back to the study site by 83 patients and these were analyzed. Health-related quality of life was significantly lower in five of the six functional scales (physical functioning, role functioning, cognitive functioning, social functioning, global health status) and in eight of the nine symptom scales (fatigue, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) compared to the reference values of a German normal population. CONCLUSIONS: The EORTC QLQ-C30 questionnaire is suitable for the acquisition of the health-related quality of life in formerly critically ill patients. Health-related quality of life is severely impaired after mechanical ventilation in the intensive care unit. Future studies should consider health related quality of life as a possible study endpoint.

Quality of life after liver transplantation.

Quality of life (QoL) is an outcome criterion of increasing importance after orthotopic liver transplantation (OLT). The background of this development is the dramatic improvement in patient survival rates over the past two decades combined with the question of the quality of this survival. Among 339 OLT performed in Kiel since 1987, 123 recipients (70 males, 53 females) of mean age 56.7 +/- 13.1 years who underwent transplantation between August 1992 and June 2007 were subjected to European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 plus a liver transplant specific module to analyze QoL. In addition, we included 40 patients listed for OLT in the univariate and multivariate analyses performed using SPSS13.0. A cohort of healthy individuals served as the control group. QoL (global health) among liver recipients was reduced compared with the control group and improved compared with patients on the waiting list. Comparison of the underlying liver diseases showed a comparable QoL between postalcoholic cirrhosis and cholestatic liver diseases. Retransplantation was accompanied by a significant loss of QoL. Cyclosporine-treated recipients displayed a better QoL compared with those treated with tacrolimus. After establishing a system of continuous, systematic QoL assessment, we combined these results with survival outcomes. Further research must focus on advanced statistical methodology that combines these 2 major outcome parameters (QoL and survival). Furthermore, the influence of medical parameters, such of co-morbidity or immunosuppression, needs to be further established with reference to QoL.

[Patient satisfaction--a potential cornerstone of hospital management]. / Patientenzufriedenheit--Ein potentieller Eckpfeiler des Krankenhausmanagements.

BACKGROUND: Hospitals consider themselves to be exposed to intense competition for patient admissions. Yet their competitive performance is only rarely assessed in terms of patient satisfaction. METHODS: Following agreed guidelines, formulated on the basis of interdisciplinary research, the University Clinical Centre (2,500 beds, 10,000 employees) of Schleswig Holstein, Germany's most northerly Bundesland, developed and distributed standardized questionnaires on patient satisfaction and collected them after completion. RESULTS: 18,711 completed questionnaires were collected from a population of 71,000 treated patients (rate of return: 26%; males 50,6%; females 49,4%). Two-thirds of admissions were elective whereas the remainder were emergencies. The quarterly evaluation revealed quality of food and cleanliness as the main areas of complaint. Patients' dissatisfactions was the greater the longer the stay in hospital. Other differences between patients on statutory or private health insurance, respectively, were voiced regarding "respectful treatment" and "professional ability" (especially by private patients). Furthermore, patient satisfaction related to the duration of doctors' rotation (i.e. how long they were on duty), satisfaction being greater the longer the period of rotation. CONCLUSION: The study has provided information on patient satisfaction as a measure of effective hospital management.

Prostate-specific symptoms of prostate cancer in a German general population.

Predominant symptoms in prostate cancer patients are erectile dysfunctions and urinary problems. As decreases of these functions can be attributed to disease and treatment but also to age-related decreases, we conducted a study on a German reference population measuring general quality of life (QoL) as well as prostate-specific symptoms. In cooperation with a German health insurance company, 3000 questionnaires were mailed to a randomly selected sample of men aged 45-75 years. Questionnaires used were the EORTC QLQ-C30 and a prostate-specific module (PSM). One thousand one hundred and fifty questionnaires were returned (response rate: 37.6%). QoL data from this reference population were compared to QoL data from a historical cohort study of prostate cancer patients following either prostatectomy or radiotherapy. In terms of general QoL, the reference population showed similar QoL scores as prostatectomy patients, but better scores than radiotherapy patients. On the PSM, the reference sample showed better overall QoL, but a surprisingly high extent of erectile dysfunction, urinary problems and psychic strain. Taking into account the sensitive topic of this study (sexuality and urinary problems), the response rate is more than satisfying. Older men in our randomly selected, population-based sample do not show perfect erectile and urinary function. These findings should be considered when interpreting QoL data of prostate cancer patients.

[Quality of life and sexuality after surgery for rectal cancer--a follow-up study]. / Sexualität und Lebensqualität bei Patienten mit Rektumkarzinomen.

BACKGROUND: Previous studies have suggested that sexuality following surgery for rectal cancer is better in women than in men and differs with type of surgery in terms of impact on Quality of Life. However, the findings were inconsistent. The aim of the presented study was to address these issues. METHODS: 570 patients that had undergone surgery for rectal cancer in our department from 1992 to 1999 were included. After determination of survival status questionnaires on Quality of Life were sent to 370 patients one to two years post surgery. We analysed data from 215 patients of which 103 were female and 112 male. 248 patients died during the time observed. Statistical analysis was done with descriptive methods, Kaplan-Meier analysis (log rank test), T-test and analysis of variance using SPSS 11.0 for Windows. RESULTS: Significant differences were seen in symptom scales between men and women. Women scored higher for distress through medical treatment and had higher values for insomnia, fatigue and constipation. Both sexes had impaired sexual life but men had significantly higher values and felt more distressed by the impairment of sexuality than women. For patients receiving abdominoperineal resection sexuality was most impaired. Anterior resection with pouch had a detrimental effect on diarrhoea and treatment strain. CONCLUSION: The study showed that sexuality is influenced by gender and type of surgery and impacts Quality of Life after surgery for rectal cancer. Assessing quality of life with generic and specific instruments is helpful to determine differences between surgical procedures, age, gender, and adjuvant therapy where standard parameters such as survival have their limitations.

Factors influencing sexual function in patients with rectal cancer.

Only few studies have investigated the impact of surgery for rectal cancer on sexual function. Little of that research included quality of life (QoL) aspects and hardly any study analyzed the impact of age, gender and type of surgery on sexual function. The aim of the presented study was to address these issues. Over a 5 y period, EORTC-QLQ-C-30 and a tumor-specific module were prospectively administered to patients before surgery, at discharge, 3, 6, 12 and 24 months postoperatively. Comparisons were made between patients receiving abdominoperineal resection (APR), anterior resection (AR) with or without Pouch and Sigmoid resection. Furthermore, effects of surgery on female and male patients, and age groups were analyzed. A total of 819 patients participated in the study: 412 were males and 407 were females. The groups were comparable in terms of adjuvant treatment, tumor stage and histology. Patients after APR and AR with Pouch had worst sexual function. Men reported significantly more difficulties with sexual enjoyment; furthermore, over time, sexual problems created high levels of strain in men that were worse than baseline levels in the early postoperative period. These problems tended to remain. Patients aged 69 y and younger scored higher for problems with loss of sexual function and sexuality-related strain than patients aged 70 y and older. The findings in this study confirm that QoL changes postsurgery and that factors like type of surgery, gender and age have tremendous impact on sexual function and sexual enjoyment. APR and AR with Pouch affect sexual function more than AR and resection of the lower sigmoid. Through impaired sexual enjoyment, men are put more under strain than women. Patients aged 69 y and younger experience more stress through deteriorated sexual function.

Migration of lubricants from food packagings. Screening for lipid classes and quantitative estimation using normal-phase liquid chromatographic separation with evaporative light scattering detection.

A normal-phase high-performance liquid chromatography (NP-HPLC) method is introduced for the identification and quantitative estimation of 12 lipid classes (paraffin, wax esters, cholesterol esters, fatty acid methyl esters, triacyl glycerols, fatty alcohols, free fatty acids, cholesterol, 1,3-diacyl glycerols, 1,2-diacyl glycerols, monoacyl glycerols and fatty acid amide) used as lubricantsin food packaging materials. The HPLC separation is carried out on a LiChrospher Diol (100 A, 5 microm, 125 mm x 3 mm) column with gradient elution (isooctane/0.1% acetic acid in tert-butyl methyl ether) and evaporative light scattering detection (ELSD). The method has been calibrated with representatives of each class in working ranges of about 5-150 mg/l, depending on the lipid class. Intra-day variance for all representatives range from 1.9 to 5.1%, inter-day variances from 7.0 to 26.5% and the limits of detection from 0.79 to 3.65 mg/l (except for two classes). A simple sample preparation could be established for the determination of migrating lubricants obtained from packaging materials containing external or internal lubricants. Since the detector response depends on the chain length and the degree of saturation, the quantification of a lipid class with unknown composition is only semi-quantitative. The amount of migrating lubricants from an epoxy-based can coating could be estimated with 0.3 mg/dm2 and from a light weight container with 5.5 mg/dm2.

Development of a disease specific questionnaire to supplement a generic tool for QoL in colorectal cancer.

The need for disease-specific quality of life measures is highlighted in the literature. The psychometric properties of a supplementary disease-specific quality of life questionnaire developed for use with a generic Quality of Life tool in colorectal cancer patients are explored. Originally developed and tested in a German sample, the English translation was tested on a cohort of UK colorectal cancer patients. Relevance and acceptability was previously established in Germany. A rigorous factor analysis ascertained the underlying structure of two factors with a number of single items that were retained as clinically important symptom indicators. In considering validity, four conditions were assessed: Reliability using Cronbach's alpha; Construct validity by comparing patient subgroups; Clinical Validity, by testing the hypothesis that some patient subgroups experience worse quality of life; Construct Reliability using second order factor analysis with the EORTC QOLQ-C30 scales, confirming that the factors retained provide an excellent measure of physical discomfort and a good measure of physical well being. Two other such questionnaires were developed in parallel with this one and reported in the literature (FACT-C and QOLQ-CR38). However, this questionnaire provides a useful alternative tool for use in clinical trials of colorectal cancer treatments alongside a core QoL questionnaire especially when brevity is an important consideration.

[A concept for the assessment of quality of life in patients with carcinomas of the upper aerodigestive tract]. / Konzept zur Erhebung der Lebensqualität bei Patienten mit Karzinomen des oberen Aerodigestivtraktes.

BACKGROUND: The quality of life (QoL) of patients with malignant diseases decreases significantly. OBJECTIVE: The evaluation of QoL is generally not part of the management of patients with head and neck cancer. The aim of this study was to develop an additional disease- and treatment-specific questionnaire to evaluate QoL in surgically treated head and neck cancer patients. PATIENTS AND METHODS: The general QoL was evaluated with the QLQ-C30 questionnaire developed by the European Organisation of Research and Treatment of Cancer (EORTC). RESULTS: The disease-specific QoL was evaluated using the EORTC H&N35 module. The new questionnaire "Kiel Head and Neck 17" (KQL H&N-17) is a disease- and treatment-specific addition especially in regard to side effects caused by surgical treatment. CONCLUSIONS: A wide application of this whole concept is needed to obtain comparable results from studies suitable for evaluating QoL in patients receiving different treatments for their malignant diseases. Moreover, the effectiveness and quality of treatment could be controlled better, which would help to increase the QoL of these patients.

[Measurement of the outcome quality as beginning of total quality management in otorhinolaryngology]. / Messung der Ergebnisqualität als Ansatz zum Qualitätsmanagement in der Hals-Nasen-Ohrenheilkunde.

BACKGROUND: The last years are characterized by a change of paradigms in the evaluation of medical therapeutical strategies. The term quality of life (QoL) has been established in oncology and could be demonstrated as a subject of highly qualified investigations which were published during the last years. An extendend quality management is correlated with the possibility of cost-effectiveness measurement and arrangement in a time characterized by decreasing financial resources of the hospitals and university departments. The experiences in the field of quality analysis could offer precious tools to optimize structures, processes and results of treatments. This aim is strongly supported by the expected law "Gesundheitsreform 2000". METHOD AND RESULTS: Therefore reliable, valid tools are needed to calculate the effects of therapies. The combination of global and specific questionnaires include the possibility to compare oncologic data of different entities of malignomas. A couple of questionnaires in otorhinolaryngology were developed in the last decade involving the fields of malignomas of the upper aerodigestive tract, rhinosinusitis etc. CONCLUSIONS: Ishikawa, the founder of "Total Quality Management" and of the "Quality Circ", pointed out the high importance of customer satisfaction. Whereas the patient is in the mid point of medical treatment there are hardly any investigations about customer satisfaction published. Therefore it is necessary to develop and establish validated tools for the measurement of quality dimensions. The short, middle and long-lasting effects of a treatment could be calculated by quality of life measurements. The QoL is here of very strong importance, especially since economic aspects are included.

Application of GC-MS/MS for the analysis of PCDD/Fs in sewage effluents.

The application of high resolution gas chromatography in combination with tandem mass spectrometry in an ion trap was tested to substitute the expensive high resolution mass spectrometry in analysing polychlorinated dibenzo-p-dioxins and furans in sewage effluents. In tandem mass spectrometry, a set of parameters has to be optimised in order to attain the required sensitivity. To the best of our knowledge, this is the first time a method development for analysing PCDD/Fs with GC-MS/MS in an ion trap is described in this detail. Nine parameters are varied, including isolation window, collision induced dissociation (CID) amplitude, CID time, acquisition mass range, broadband amplitude, CID bandwidth, modulation range, filament current and ion trap temperature. This technique can be adapted to other analytes. By this optimisation, limits of detection of 0.01-0.05 ng/l are obtained. With its selectivity and sensitivity, tandem mass spectrometry is a powerful tool for the determination of PCDD/Fs in water samples. 55 sewage effluent samples from Germany were analysed.

[Not Available]. / Weiterbildung PsychoSoziale Onkologie: Konzeption, Erfahrungen und erste Evaluationsergebnisse/ Professional psychosocial oncology: Conception, experience and first results of the evaluation.

Since 1994 there is a continuous education program on psychooncological topics for medical doctors, psychologists and other oncological caregivers. This program is organised and conducted by the workinggroup "Psychooncology" (PSO) within the German Cancer Society in cooperation with the "Workinggroup for Psychosocial Oncology" (dapo). This standardised education program can be seen as a measure of quality assurance and a first step toward developing Standards for psychooncological care in Germany. Up till now 262 participants attended the program. First results of the continuous evaluation showed a high level of satisfaction with the concept and the didactics of this curriculum. However, the interdisciplinary orientation of this program in terms as well of content as of professional diversity among the participants serves as a constant challenge to improve contents, didactics and appropriate evaluation.

[Concepts for measuring quality of life in patients with chronic sinusitis]. / Konzept zur Messung der Lebensqualität bei Patienten mit chronischer Sinusitis.

BACKGROUND: In 1997, Benninger developed the Rhinosinusitis Disability Index (RSBI) for patients who suffered from chronic sinusitis. Its content related validity and construct related validity were established, as were its sensitivity and reliability. The aim of our study is to introduce a concept to measure quality of life in these patients according to circumstances prevalent in Germany. METHODS: The questionnaire (Rhinusitis-Beeinträchtigungs-Index, RSBI) contains 30 questions that describe the 5 aspects of quality of life. Moreover we used a standardized data sheet to acquire further information about history and diagnostic results. Using this method it is possible to specificity more precisely the patients current complaints and condition. Evaluation is possible according to complex of questions as well as simple items. The influence of treatment on quality of life can be measured as the sum of the specific scores and is expressed comprehensively in the total score. The concept of the study includes a prospective inquiry as well as before and after surgical intervention. CONCLUSION: A disadvantage of the American RSDI is that the clinical symptoms are not described in a detailed catalogue which allows the correlation of the clinical factors. Therefore we added a detailed questionnaire concerning the clinical symptoms and the individual treatment of the patient (RSBI). That permits comprehensive analysis of quality of life as it relates to different aspects of disease and different strategies in treatment.

How important is the route of reconstruction after esophagectomy: a prospective randomized study.

OBJECTIVE: A prospective randomized trial was performed to compare retrosternal and posterior mediastinal gastric tube reconstruction with regard to postoperative function and quality of life. METHODS: Twenty-six patients were randomly allocated to either retrosternal (n = 14) or posterior mediastinal (n = 12) reconstruction after gastric tube formation. Radionuclide transit studies were applied to obtain objective functional data and a standardized quality-of-life assessment was performed. RESULTS: Retrosternal reconstruction showed an increased morbidity (15 vs 13 major complications) and mortality (14.2 vs 8.3%). Radionuclide clearance in the supine position was delayed in the gastric tube in general, compared with normal controls (retention index > 40% vs < 10%). There was a significantly higher retention (p < 0.005) in the retrosternal group in the middle third of the tube and the whole tube after intake of the liquid tracer. The retention of the first solid tracer was also higher in the retrosternal group in the middle third of the tube (p = n.s.) and was significantly higher in the whole tube after 30 (p < 0.05) and 60 (p < 0.01) s. This had no significant impact on the patients' quality of life. CONCLUSIONS: The posterior mediastinal route of reconstruction is recommended but curative resection (R0) is mandatory to avoid possible complications due to local tumor relapse. After incomplete resection (R1 or R2) we recommend retrosternal reconstruction for better palliation.

Impact of psychotherapeutic support on gastrointestinal cancer patients undergoing surgery: survival results of a trial.

BACKGROUND/AIMS: The impact of psychotherapeutic support on survival time in patients with gastrointestinal cancer undergoing surgery was studied. METHODOLOGY: A randomized controlled trial was conducted in cooperation with the Departments of General Surgery and Medical Psychology, University Hospital of Hamburg, Germany. Two hundred and seventy-one consenting patients with a preliminary diagnosis of cancer of the esophagus, stomach, liver/gallbladder, pancreas or colon/rectum were stratified by gender and randomly assigned to a control group that received standard care, as provided on the surgical wards, or to an experimental group that received formal psychotherapeutic support in addition to routine care during the hospital stay. Patients in both groups completed the EORTC-Quality of Life questionnaire pre-operatively, post-operatively, and at 3, 6, 12, and 24 months following surgery. Date of death, if applicable, was also recorded. Unadjusted and adjusted survival analyses were performed. RESULTS: Kaplan-Meier survival curves demonstrated better survival for the experimental group than for the control group. The unadjusted significance level for group differences was p = 0.002 for survival up to 2 years. Cox regression models that took TNM Staging or the Residual Tumor Classification into account also found significant differences at the 2-year follow-up. Secondary analyses found that most of the differences in favor of the experimental group occurred in females and in patients with stomach, pancreatic, primary liver or colorectal cancer. CONCLUSIONS: The results of this study indicate that patients with gastrointestinal cancer, particularly those who are female and those who undergo surgery for stomach, pancreatic, primary liver or colorectal cancer, benefit from a formal program of psychotherapeutic support in terms of survival.